Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-31 @ 3:44 PM
Study NCT ID:
NCT00667693
Status:
COMPLETED
Last Update Posted:
2018-07-24
First Post:
2008-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pentax Airway Scope (AWS) Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sesslerd@ccf.org', 'phone': '216-445-8396', 'title': 'Daniel I Sessler, MD', 'organization': 'Cleveland Clinic Foundation'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'It focused on obese patients; did not include patients with a history of difficult intubation; protocol did not include use of adjunctive devices; was impossible to blind the operator to the device being used; only the Mallampati score was recorded'}}, 'adverseEventsModule': {'timeFrame': 'From the start of intubation until 24 hours after surgery', 'eventGroups': [{'id': 'EG000', 'title': 'Macintosh', 'description': 'Intubation with a Macintosh laryngoscope\n\nMacintosh intubation: Macintosh intubation', 'otherNumAtRisk': 49, 'otherNumAffected': 0, 'seriousNumAtRisk': 49, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Pentax', 'description': 'intubation with a the Pentax AWS\n\nPentax AWS: Intubation with Pentax AWS', 'otherNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Intubation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Macintosh', 'description': 'Intubation with a Macintosh laryngoscope\n\nMacintosh intubation: Macintosh intubation'}, {'id': 'OG001', 'title': 'Pentax', 'description': 'intubation with a the Pentax AWS\n\nPentax AWS: Intubation with Pentax AWS'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '29'}, {'value': '38', 'groupId': 'OG001', 'lowerLimit': '31', 'upperLimit': '50'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.35', 'ciLowerLimit': '0.23', 'ciUpperLimit': '0.55', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'time between sufficient muscle relaxant and placement of intubation tube, up to 100 seconds', 'description': 'time between sufficient muscle relaxant and placement of intubation tube', 'unitOfMeasure': 'seconds', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ease of Intubation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Macintosh', 'description': 'Intubation with a Macintosh laryngoscope\n\nMacintosh intubation: Macintosh intubation'}, {'id': 'OG001', 'title': 'Pentax', 'description': 'intubation with a the Pentax AWS\n\nPentax AWS: Intubation with Pentax AWS'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'spread': '28', 'groupId': 'OG000'}, {'value': '52', 'spread': '31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the start of intubation until 24 hours after surgery', 'description': 'Ease of intubation was recorded by the operator immediately after intubation on a 100 mm visual analog scale (VAS). The score ranges from 0 to 100. A higher score indicates more difficulty in intubation', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Successful Intubation on the First Attempt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Macintosh', 'description': 'Intubation with a Macintosh laryngoscope\n\nMacintosh intubation: Macintosh intubation'}, {'id': 'OG001', 'title': 'Pentax', 'description': 'intubation with a the Pentax AWS\n\nPentax AWS: Intubation with Pentax AWS'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the start of intubation until 24 hours after surgery', 'description': 'The count number of successful intubation on the first attempt', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Number of Patients With Different Number of Intubation Attempts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Macintosh', 'description': 'Intubation with a Macintosh laryngoscope\n\nMacintosh intubation: Macintosh intubation'}, {'id': 'OG001', 'title': 'Pentax', 'description': 'intubation with a the Pentax AWS\n\nPentax AWS: Intubation with Pentax AWS'}], 'classes': [{'categories': [{'title': 'one attempt', 'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}, {'title': 'two attempts', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'three attempts', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the start of intubation until 24 hours after surgery', 'description': 'We summarized the number of patients with one, two or three intubation attempts.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Number of Patients With Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Macintosh', 'description': 'Intubation with a Macintosh laryngoscope\n\nMacintosh intubation: Macintosh intubation'}, {'id': 'OG001', 'title': 'Pentax', 'description': 'intubation with a the Pentax AWS\n\nPentax AWS: Intubation with Pentax AWS'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the start of intubation until 24 hours after surgery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Macintosh', 'description': 'Intubation with a Macintosh laryngoscope\n\nMacintosh intubation: Macintosh intubation'}, {'id': 'FG001', 'title': 'Pentax', 'description': 'intubation with a the Pentax AWS\n\nPentax AWS: Intubation with Pentax AWS'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Macintosh', 'description': 'Intubation with a Macintosh laryngoscope\n\nMacintosh intubation: Macintosh intubation'}, {'id': 'BG001', 'title': 'Pentax', 'description': 'intubation with a the Pentax AWS\n\nPentax AWS: Intubation with Pentax AWS'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49', 'spread': '14', 'groupId': 'BG000'}, {'value': '50', 'spread': '12', 'groupId': 'BG001'}, {'value': '49', 'spread': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'ASA status', 'classes': [{'title': 'II: mild systemic disease', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'III: severe systemic disease', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}, {'title': 'IV: severe systemic disease that threats to life', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'American Society of Anesthesiology (ASA) physical status classification system', 'unitOfMeasure': 'participants'}, {'title': 'Mallampati score', 'classes': [{'title': '1: Soft palate, uvula, fauces, pillars visible', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}, {'title': '2: Soft palate, uvula, fauces visible', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}, {'title': '3: Soft palate, base of uvula visible', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': '4: Only hard palate visible', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-23', 'studyFirstSubmitDate': '2008-04-24', 'resultsFirstSubmitDate': '2016-07-18', 'studyFirstSubmitQcDate': '2008-04-24', 'lastUpdatePostDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-09-13', 'studyFirstPostDateStruct': {'date': '2008-04-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Intubation', 'timeFrame': 'time between sufficient muscle relaxant and placement of intubation tube, up to 100 seconds', 'description': 'time between sufficient muscle relaxant and placement of intubation tube'}], 'secondaryOutcomes': [{'measure': 'Ease of Intubation', 'timeFrame': 'From the start of intubation until 24 hours after surgery', 'description': 'Ease of intubation was recorded by the operator immediately after intubation on a 100 mm visual analog scale (VAS). The score ranges from 0 to 100. A higher score indicates more difficulty in intubation'}, {'measure': 'Successful Intubation on the First Attempt', 'timeFrame': 'From the start of intubation until 24 hours after surgery', 'description': 'The count number of successful intubation on the first attempt'}, {'measure': 'The Number of Patients With Different Number of Intubation Attempts', 'timeFrame': 'From the start of intubation until 24 hours after surgery', 'description': 'We summarized the number of patients with one, two or three intubation attempts.'}, {'measure': 'The Number of Patients With Bleeding', 'timeFrame': 'From the start of intubation until 24 hours after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['intubation', 'obese'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'This study will compare the Macintosh laryngoscope with the Pentax. The Pentax AWS is a novel airway management device that is designed to facilitate laryngoscopy and endotracheal intubation.', 'detailedDescription': '100 obese patients (BMI 30 to 50) requiring orotracheal intubation for elective surgery will be randomly allocated to intubation with either a conventional Macintosh laryngoscope or with the Pentax AWS. Our study hypothesis is that use of Pentax AWS will make tracheal intubation easier to perform in the obese surgical patient (BMI 30 to 50), as evidenced by the time to complete the intubation process as well as an "Ease of Use" visual analog score (VAS) measure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subject is at least 18 years old\n* BMI between 30 and 50\n* scheduled for elective surgery requiring orotracheal intubation\n\nExclusion Criteria:\n\n* a known difficult airway\n* loose teeth\n* subject pregnancy\n* rapid sequence induction required\n* subject is unable to give consent\n* anesthesiologist considered use of the Pentax AWS to be contraindicated\n* special endotracheal tube (ETT) is needed for the case.'}, 'identificationModule': {'nctId': 'NCT00667693', 'briefTitle': 'Pentax Airway Scope (AWS) Intubation', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'A Randomized Comparison Between the Pentax AWS Video Laryngoscope and the Macintosh Laryngoscope', 'orgStudyIdInfo': {'id': '08-046'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Macintosh laryngoscope', 'description': 'Intubation with a Macintosh laryngoscope', 'interventionNames': ['Device: Macintosh laryngoscope']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pentax AWS', 'description': 'Intubation with a Pentax AWS', 'interventionNames': ['Device: Pentax AWS']}], 'interventions': [{'name': 'Macintosh laryngoscope', 'type': 'DEVICE', 'description': 'Intubation with Macintosh laryngoscope', 'armGroupLabels': ['Macintosh laryngoscope']}, {'name': 'Pentax AWS', 'type': 'DEVICE', 'description': 'Intubation with Pentax AWS', 'armGroupLabels': ['Pentax AWS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Daniel I Sessler, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'The Cleveland Clinic'}, {'name': 'John Doyle, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}